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Titan Spine wins 510(k) for spinal fusion implant

Wisconsin's Titan Spine announced today that it received 510(k) clearance from the FDA for its Endoskeleton TL System implant for spinal fusion.

The key feature of the product is its roughened titanium surface technology, which promotes bone growth and fusion, according to the company. In addition, it is implanted using the less invasive lateral approach, which involves cutting a 3-cm incision on the side of the patient, according to the University of Pittsburgh.

"The Endoskeleton TL device is the first application of surface technology to the lateral approach," said Titan Spine Chief Medical Officer Dr. Paul Slosar in a statement. "The ability to orchestrate cellular behavior and promote bone growth in response to an interbody device has not been in the lateral surgeon's armamentarium until now. The TL is the byproduct of a unique collaboration between academic biomaterial scientists, spine surgeons and industry experts to create a truly differentiated lateral interbody device that is designed to benefit both patients and surgeons."

The implant is the privately held company's sixth product for spinal fusion in the cervical and lumbar joints; all products feature its proprietary surface technology.

According to a recent analysis by the federal Agency for Healthcare Research and Quality, spinal fusion surgery increased 70% between 2001 from 2011, or from 288,000 to 488,000 procedures per year. But GlobalData research analyst Joseph Gregory believes a market correction is under way, and wrote in a research report emailed to FierceMedicalDevices that Medicare estimates $200 million was spent on unnecessary procedures.

"Originally, insurers issued reimbursement payments as long as the hospital properly coded the procedure. Now, the payers are requiring extensive documentation to validate the medical necessity of the procedure, including well-documented attempts at conservative care (including the duration and type) and radiographic imaging documenting the source of pain," the report said. "If the documentation is found to be insufficient, then the procedure is either denied coverage or insurers will retrospectively deny coverage and force the hospitals to pay back the money they received," it continued.

As a result, Gregory estimated that the volume of procedures will increase at a compounded annual growth rate of 5% through 2020, instead of the previous 10%, but that still represents a 40% increase from 2013 to 2020.

As of 2012, Medtronic's ($MDT) spinal products (both fusion and non-fusion-related) had a 32% market share, followed by DePuy at 22% and Stryker with 11%. GlobalData estimated that by 2020 the spinal fusion market will be worth $4.4 billion in the U.S., $684 million in Japan and $665 million in China.